Access to Vaccines & the Econom ic Landscape Arizona VFAAC Meeting, 9-19-14 Phyllis Arthur Senior Director Vaccines, Immunotherapeutics & Diagnostics Policy parthur@bio.org
I ntroduction Vaccines have had a dramatic impact on the health of Americans. – One of the few forms of clinical primary prevention. – Considered one of the best public health interventions of the 20 th c. Collaboration among government, public and private healthcare providers, and vaccine companies has made this success possible. Vaccine companies are committed to public health and their partnership with immunization stakeholders. The Vaccines for Children (VFC) Program is a clear illustration. – VFC is one of our nation’s most successful public-private partnerships. – Congress intended the VFC program to provide free vaccines to vulnerable children while not disrupting the private marketplace. – VFC celebrated its 20 th anniversary this year.
I ntroduction Cont. Companies are investing in a broad range of novel and improved vaccines to protect people of all ages from disease. To continue this progress, there must be a balanced vaccine ecosystem with a viable vaccination environment.
Manufacturers Serve a Key Role in the Battle against I nfectious Diseases Manufacturers are best positioned to develop and produce vaccines Extensive expertise Future innovation, however, is dependent on an adequate return on investment. State-of-the-art facilities Capital independent of government grants
Past Concern over Num ber of Vaccine Manufacturers Led to Policy Changes In the 1970s and 1980s, litigation against vaccine manufacturers had forced all but one manufacturer of DTP out of the market. The U.S. government became concerned that the country’s vaccine supply was at risk. To prevent such shortages, Congress enacted unique legislation in 1986 creating a program to govern liability and preserve a viable vaccine industry, known as the National Vaccine Injury Compensation Program (VICP). VICP protects patients, providers and manufacturers.
These Changes Helped Stim ulate New Entrants into a Grow ing Market Over the last 2 decades, more than a dozen new vaccines have been introduced and the number of companies developing products has increased. Companies can increase investment in vaccines because new vaccines can now demonstrate comparable Returns on Investment (ROI) relative to new biologicals and pharmaceuticals. Large and small companies, as well as investors, are continually assessing these ROI’s and making decisions on resource allocation priorities. Beyond 1990 1970 1980 2000 30+ Companies 6 Manufacturers 3 Manufacturers Conducting Vaccine R&D and manufacturing
More Com panies Are Now Contributing to Greater I nnovation Targets for vaccine development include traditional viruses and bacteria, and also non- communicable diseases. Vaccines may become a key part of anti-microbial stewardship programs. Over the next decade, we may see: New Adult or Pediatric New Healthcare-acquired New Vaccines for Infection Vaccines Vaccines Global Health Universal influenza Clostridium difficile Malaria Meningococcal A,C, Y, W-135 Staphylococcus aureus Dengue Tuberculosis Meningococcal B Ebola CMV Pseudomonas aeruginosa Tuberculosis RSV Candida Chikungunya Streptococcus vaccines Norovirus New combinations of existing pediatric vaccines
Vaccines Present a Unique Need for Continuous I nvestm ent Higher costs for vaccines may reflect: – Constant maintenance and FDA-required upgrades of facilities – Processes and ongoing programs to improve current vaccines – New clinical development programs – Large clinical trial sizes – Post-marketing requirements for safety Over time, costs (and therefore prices) may actually increase due to the labor-intensive nature of manufacturing vaccines and to increasing regulatory requirements.
Vaccines Present a Unique Need for Continuous I nvestm ent Increasing Costs New Vaccine Development s Indications Maintenance Technology R&D Facility New R&D Introduction Product Timeline
Difficult Clim ate for Many Stakeholders As vaccine companies face higher cost pressures, healthcare providers are grappling with higher transactional costs. – Some public health clinics and small volume private providers may find these more difficult to manage. ACA is a major step forward but not necessarily a fix-all. – ACA helped the consumer, not the clinician. – ACA may cause some insurers to reevaluate provider payments as they implement the ACA requirements for coverage. – In 2013, 36% of covered workers were enrolled in grandfathered health plans nationwide. – In AZ, many are covered by self-insured plans not yet subject to the ACA immunization coverage standard. Options are available to help providers access vaccines in the private sector.
Vaccine Manufacturers Have Many Options to Help Providers Directly For example: Provider offices set up an account directly with specific manufacturers. Method often used by pediatric offices and some large FP offices Flexible Contract Terms and Conditions: – Extend time for payment – On-invoice discounts – Incremental discounts based on specified criteria – Return policies – Etc.
Vaccine Manufacturers Participate in Organizational I nitiatives Provider Purchasing Organizations – Networks of providers who contract directly with manufacturers on behalf of members – Contracts may include flexible terms e.g. on-invoice discounts and rebates to the organization / members – Delivery of doses for these contracts is often direct from the manufacturer – Example: In Ohio, the AAP manages a purchasing organization for its members. Group Purchasing Organizations ( GPOs) – Networks of institutions (e.g. hospital systems) who contract with manufacturers on behalf of members – Contracts may include flexible terms e.g. on-invoice discounts and rebates to the organization / members – Delivery of doses for these contracts is often through wholesalers on behalf of the manufacturer
Vaccine Manufacturers Participate in Organizational I nitiatives Cont. Third Party Procurem ent & Billing ( e.g. VaxCare) – VaxCare handles vaccine procurement & management, claims processing, and patient billing. – Physicians must only: Order vaccine and supplies through VaxCare portal at no cost Vaccinate their patients and register their information in the VaxCare system. Collect any out-of-pocket payments. – VaxCare offers different solutions for private physicians & health departments.
Distributors Often W ork w ith Providers and Hospitals Directly There are two primary types of distributors: – Physician distributors: Distributors of health care products and services to office-based practitioners / clinics – Wholesalers: Distributors of health care products and equipment to a broader array of health care settings (clinics, hospitals, nursing homes) Distributors offer access to a large variety of provider/ clinic office supplies, including vaccines. – Most often used by non-pediatrician, primary care offices and large hospital systems Providers can therefore access vaccines from various manufacturers from one place. Distributors may offer deals across a wide array of products. Some manufacturers direct providers to distributors.
Other Resources for Manufacturers to Help Providers Manufacturers have various communication links with providers. ▫ In-office representatives ▫ Phone representatives ▫ Distributor representatives In some instances, companies may be able to assist with: ▫ Contracts and purchasing options ▫ Inventory management ▫ Order placement ▫ Staff training ▫ Patient educational materials Access to organizations that specialize in helping providers with reimbursement problems for vaccines Office tool kits to help the office establish immunization infrastructure
Valuable Resources from Other Key Sources Immunization tool kits – AMA – AAP ACOG – ACP CME programs for physicians and nurses on coding and billing – AMA – ACOG – AAFP
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